Profounda Inc – FDA 483, Aug 9, 2022

Profunda Inc, an OTC drug manufacturer in Orlando, FL, was cited for significant deficiencies across its quality, laboratory, facilities, and production systems during an FDA inspection. Key issues include inadequate complaint handling, lack of investigations for out-of-specification results and missing data, deficient laboratory controls, unsupported expiration dates, and unvalidated manufacturing processes and water systems. These observations indicate a broad lack of adherence to cGMP requirements.